FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2041146
·
Received March 29, 2011
Report
- Report Number
- 1644487-2011-00662
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- September 15, 2008
- Report Date
- March 1, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A VNS TREATING PHYSICIAN SUBMITTED AND ADVERSE EVENT FORM ON (B)(6) 2011 FROM AN E102 STUDY IN (B)(6) INDICATING THE VNS PT ACQUIRED A POST-OPERATION INFECTION FOLLOWING VNS IMPLANTATION. THE INFECTION STARTED AFTER IMPLANT ON (B)(6) 2008 AND LASTED TILL (B)(6) 2008 WHEN THE DEVICE WAS EXPLANTED AND THE PT WAS RE-IMPLANTED WITH ANOTHER GENERATOR. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN TO NO AVAIL THUS FAR. IF ADDITIONAL INFORMATION IS RECEIVED THEN IT WILL BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Hospitalization| R |